Kornimate/medical-research-clean huggingface dataset:
a phase 1 pilot study of the subcutaneous (s.c.) route to facilitate the administration of rrx-001

Conditions: Malignant Solid Tumor; Lymphomas

Summary: to investigate the dosage of rrx-001 by the subcutaneous route.

this is a phase i, open-label, dose-escalation study of rrx-001. subjects will receive rrx-001 administered as subcutaneous injections twice weekly for at least 8 weeks. at least three subjects must complete 2 weeks of treatment with rrx-001 at each dose level, before escalation to the next higher rrx-001 dose level; 2 doses-16 and 27 mg/m2- will be tested. the purpose of the study is to extend the dosage options for rrx-001 since faster subcutaneous (sc) administration may increase convenience versus the traditional iv method. the study also will also measure the mean concentrations of an rrx-001 metabolite in the blood (pharmacokinetics; pk) versus the iv formulation.

Eligibility criteria:
inclusion criteria: * at least 18 years old. * ecog (performance) status of 0, 1 or 2. * histologically or cytologically confirmed primary or metastatic advanced solid tumors or lymphoma. subjects with curative treatment options are not eligible for the protocol. * no active ongoing cancer treatment (except for prostate cancer subjects receiving luteinizing hormone-releasing hormone (lhrh) agonists and anti-androgens such as; flutamide, dutasteride, and finasteride). * adequate organ and bone marrow function. * male and female subjects of childbearing potential must agree to use contraception. exclusion criteria: * pregnant or breast-feeding. * use of anti-coagulant therapy.
evaluating microarray pharmacogenetic testing in cancer patients

Conditions: Cancer; Gastrointestinal Cancer

Summary: the purpose of this research is to evaluate the impact of a microarray pgx test on prescribing/dosing of drugs and cancer treatments in patients with cancer who are currently eligible for single-gene dpyd testing.

this is a prospective, non-randomized, phase 2 study. the target population is adults ≥18 years of age who have received or will be receiving standard of care single-gene dpyd (dihydropyrimidine dehydrogenase) pgx testing to help guide dosing for their cancer treatment. pharmacogenes that will be reported back to participants and providers from the microarray test are expected to take approximately one week and will be evaluated by the pgx team and uploaded to the participant's electronic medical record (emr). only clinically actionable results per cpic and fda guidelines will be included in the participant report. participants will be followed on study for approximately 6 months to collect data on the number of drug prescriptions with known drug-gene interactions and potentially actionable results, bpas fired, and actions taken due to bpas.

Eligibility criteria:
inclusion criteria: * written informed consent and hipaa authorization for release of personal health information. * age ≥ 18 years at the time of consent. * eligible for standard of care single-gene dpyd testing (i.e., receiving or expected to receive a fluoropyrimidine-based chemotherapy regimen). the potential participant meets inclusion criteria if the standard of care single-gene dpyd test is planned or previously ordered. if previously ordered, consent must occur no later than 60 days from the date the dpyd results were available. * willing to provide additional buccal swabs if residual dna from previous dpyd testing is inadequate for microarray testing. exclusion criteria: • history of prior allogeneic hematopoietic cell transplantation or liver transplantation
study to evaluate ctdna of mcspc patients receiving apalutamide in japan

Conditions: Metastatic Castration-sensitive Prostate Cancer

Summary: to evaluate changes in genomic alterations for 73 pc driver genes during apalutamide treatment

this clinical study is an open-label, multicenter, interventional, phase 4 study to evaluate changes in genomic alterations for 73 pc driver genes during apalutamide treatment in patients with mcspc. a total of 100 participants to be treated by apalutamide will be registered in this study. all participants will undergo blood collection for ctdna, single-nucleotide polymorphisms (snps), and human-leukocyte antigen (hla) typing at pre- and posttreatment of apalutamide.

Eligibility criteria:
inclusion criteria: * men aged ≥20 years. * participant has documented diagnosis of metastatic pc with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology. * participant has metastatic pc that is castration naïve or castration sensitive and is permitted to receive less than 6-months adt or cab before registration and less than 36-months neoadjuvant or adjuvant hormonal therapy. * if a participant is treated with adt or cab, he has maintained a response to hormonal therapy of stable disease or better, by investigator assessment of imaging and psa. * participant is willing to receive apalutamide for mcspc in the participating site of this study. * participant is of japanese nationality. * participant must sign an icf indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study. exclusion criteria: * participant does not agree to assess ctdna including 73 pc driver genes, snps, and hla typing. * participant has received any prior therapy of abiraterone, docetaxel, enzalutamide, apalutamide or darolutamide. * participant has known allergies, hypersensitivity, or intolerance to apalutamide or its excipients (refer to the package insert). * participant has contraindications to the use of adt based on routine treatment. * participant has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the evaluation of active double cancer, etc.
the effect of a group exercise intervention on balance in people with knee osteoarthritis: a pilot study

Conditions: Knee Osteoarthritis

Summary: in this study, the investigators want to find out if a 12-week exercise program improves balance in people with knee osteoarthritis. this study will involve two visits to the school of kinesiology at the university of the fraser valley (chilliwack campus). each visit will last approximately one hour. participants will be asked to fill out questionnaires and complete a balance test. in between visits, participants will complete 12 weeks of an exercise program specifically designed for adults with osteoarthritis. participants will do the exercise classes twice per week. classes can be done in person or at home each exercise class is 45-minutes long and consists of flexibility, strength, and coordination exercises. in each class there are options to either increase or decrease the intensity of each exercise to cater to varying fitness levels and fluctuating symptoms. each exercise has an assisted (using a chair for balance), body weight, and resisted (weight or exercise tubing) option. participants will fill out an exercise diary each week to let the investigators know what days they did the exercise classes, and whether they experienced any changes in their knee osteoarthritis symptoms.


Eligibility criteria:
inclusion criteria: * medial compartment knee osteoarthritis, diagnosed from a physician or meeting the american college of rheumatology clinical classification criteria for osteoarthritis of the knee * pass the get active questionnaire to ensure that they are safe to begin an exercise program exclusion criteria: i) severe knee trauma, knee surgery, or intraarticular knee joint injections in the previous six months ii) active synovitis iii) concurrent neurological (i.e. parkinson's disease, alzheimer's dementia, or polyneuropathy), endocrine (i.e., diabetes mellitus) and/or vestibular disorders which may affect balance iv) chronic disease that may put them at risk during the exercise classes (i.e., history of heart failure, stroke, chronic obstructive lung disease) v) uncorrected visual impairment which may affect balance vi) an inflammatory rheumatic disease (i.e., rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and chronic reactive arthritis)

Keywords: knee osteoarthritis balance exercise
study to assess the effect of sodium zirconium cyclosilicate on the pharmacokinetics of tacrolimus and cyclosporin in healthy subjects

Conditions: Hyperkalaemia

Summary: this study will be an open-label, randomised sequence, 2-period, 2-cohort, 2-treatment in each cohort, cross-over study in healthy subjects (males and females of non-childbearing potential), performed at a single study centre.

the study will comprise: * a screening period of maximum 28 days; * two treatment periods: * treatment period 1 starts with admission to the clinical unit on day -1, followed by dosing on day 1 with the assigned treatment (a, b, c, or d) as per assigned cohort and treatment sequence, followed by a washout period of at least 14 days. * treatment period 2 starts with admission to clinical unit on day -1, followed by dosing on day 1 with cross-over treatment as per assigned cohort, followed by a follow-up period of 7 to 10 days. * a follow-up visit/early termination visit at 7 to 10 days after the last investigation medicinal product (imp) administration. subjects will be assigned to either cohort 1 (tacrolimus) or to cohort 2 (cyclosporin). each cohort will have 2 treatment periods. subjects in each cohort will be randomly assigned to one of 2 treatment sequences (ab\|ba or cd\|dc) where, * treatment a: tacrolimus * treatment b: tacrolimus + szc * treatment c: cyclosporin * treatment d: cyclosporin + szc

Eligibility criteria:
inclusion criteria: • healthy male and female subjects aged 18 to 50 years (both inclusive) exclusion criteria: * history of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study. * history or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs. * any clinically important abnormalities in rhythm, conduction or morphology of the 12-lead safety electrocardiogram (ecg), at screening visit and/or admission to the clinical unit. * has received another new chemical entity (defined as a compound which has not been approved for marketing) within 3 months of the first administration of imp in this study. * history of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to szc, tacrolimus, or cyclosporin. * subjects who have previously received szc.

Keywords: pharmacokinetics sodium zirconium cyclosilicate tacrolimus cyclosporin drug-drug interaction study
genetic determinants of congenital heart disease outcomes

Conditions: Congenital Heart Disease; Hypoplastic Left Heart Syndrome; Hypoplastic Right Heart Syndrome; d-Transposition of the Great Arteries

Summary: the purpose of this study is to examine the role of genetic variation in the oxidative stress response on critical perioperative and short-term outcomes after neonatal heart surgery. the goals will be to determine 1) if the oxidative stress pathway is an important one for therapeutic intervention in neonates with severe congenital heart defects and 2) if variants in the oxidative response pathway can be used to identify patients at increased risk for adverse outcomes.

for physicians caring for children with congenital cardiac defects, perhaps the greatest challenge is to improve the survival and functional outcomes of patients with severe defects requiring surgical repair or palliation in the first month of life. these cardiac defects can be associated with 5 year mortality rates of up to 30% with significant disabilities in many of the survivors. as with every medical condition, patient outcomes depend on the complex interaction of the disease process, the medical and surgical interventions to treat the disease, and the inherent capacity of the patient to respond to both the disease and its treatment. for patients with severe cardiac defects, the greatest risk for morbidity and mortality occurs during and shortly after their neonatal surgical repair. during surgery to repair severe cardiac defects, the body is cooled and the heart is stopped. in many cases, blood flow to the vital organs is interrupted or restricted for a significant period of time while the aortic arch is reconstructed. this process places profound stress on the patient's capacity to tolerate these insults without sustaining irreversible injury to tissues such as the heart, brain, and kidneys. that there is such a wide range of outcomes after this surgery, even between patients with similar clinical features, suggests that there are important individual differences in patients' abilities to respond to this stress that is determined by differences in their genetic traits. the importance of the interaction between the controlled trauma of the surgical environment and a patient's genetic background in determining patient outcomes has led to the new discipline of "peri-operative genomics." in this study, we will examine the contribution of gene-environment interactions to perioperative and short-term outcomes in neonates with severe congenital cardiac defects.

Eligibility criteria:
inclusion criteria: * d-transposition of the great arteries or single ventricle cardiac disease * less than or equal to 30 days of age * planned arterial switch operation or stage i surgical palliation (norwood)with aortic arch reconstruction exclusion criteria: * known trisomy 13, 18, or 21 * any major non-cardiac anomaly that precludes the patient from cardiac surgery

Keywords: neonate congenital heart disease single ventricle cardiac disease hypoplastic left heart syndrome hypoplastic right heart syndrome d-transposition of the great arteries
telemedicine to provide inflammatory bowel disease outpatient care

Conditions: Inflammatory Bowel Disease; Ulcerative Colitis; Crohn's Disease

Summary: the investigators hypothesize that outpatient clinical care of inflammatory bowel disease patients may be provided using a new computerized system over standard network - called collaborative imaging - with similar patient experience compared to a conventional clinic visit.

significant advances in gastroenterology have led the field to grow into a number of advanced subspecialties: inflammatory bowel disease (ibd), motility, therapeutic endoscopy, and transplant hepatology. telemedicine, the application of information technology in support of health care delivery from a distance, has been employed with good success in various chronic conditions with excellent patient satisfaction. primary aim: our primary study endpoint was measuring patient clinical experience between two groups: a telemedicine remote clinic visit and a standard "in-house" visit. secondary aim: to compare standard clinic metrics including clinic wait time, patient throughput, and appointment time between the two groups.

Eligibility criteria:
inclusion criteria: * adult (\> 18 years old) outpatient ibd patients in the veterans affairs medical system exclusion criteria: * va patients without ibd * hospitalized ibd patients

Keywords: telemedicine remote consultation telehealth ehealth image archiving inflammatory bowel disease
cognitive control training for depression

Conditions: Depression

Summary: depression is frequently characterized by patterns of inflexible, maladaptive, and ruminative thinking styles; these patterns themselves are thought to result from a combination of decreased attentional control, decreased executive functioning, and increased negative affect. specifically, the dorsolateral prefrontal cortex has been hypothesized to play a central role in emotion regulation by recruiting resources necessary for executive control. recent advances have been made in neurobehavioral training strategies as interventions for emotional disorders such as depression. cognitive control training (cct) uses computer-based exercises to recruit and activate prefrontal neural networks via repeated behavioral exercises, with the aim of strengthening cognitive and emotional functions. a previous study found that severely depressed participants who received cct exhibited reduced negative affect and rumination as well as improved focus and concentration. the present study aimed to extend this line of research by employing a more stringent control group and testing the efficacy of three sessions of cct over a two-week period in a community population with depressed mood. forty-eight participants with high bdi-ii scores were randomized to cct or a comparison condition (peripheral vision training; pvt). the investigators hypothesized that relative to a control condition (pvt), cct would be associated with less self-reported negative mood and emotional reactivity.


Eligibility criteria:
inclusion criteria: * bu students and local community members. * at least 18 years of age. * familiarity with a computer keyboard. * bdi-ii score ≥ 17 exclusion criteria: * bdi-ii score \ 35

Keywords: depressed mood
perioperative combination chemotherapy versus chemoradiation for locally advanced egj adenocarcinoma

Conditions: Esophagogastric Junction Disorder; Neoplasms

Summary: patients with histologically confirmed esophagogastric junction adenocarcinoma with pre-operative staging ct3-4n+m0，aged between 18-75 years old, with adequate organ function and having an eastern cooperative oncology group performance status score ≤2, are randomized in a 1:1:1 ratio to receive neoadjuvant chemoradiotherapy with dt46-50gy plus concomitant weekly oxaliplatin and 5-fu, perioperative chemotherapy of flot regimen or folfox regimen. the primary end point is disease free survival (dfs), and secondary end point is 5-year overall survival (os), pathological complete remission (pcr) and treatment safety. the final study analytics are to be conducted at the end of the 5th year after the last patient's enrollment.


Eligibility criteria:
inclusion criteria: * informed consensus of the enrolled patients * from 18 to 75 years old * proven to be primary adenocarcinoma of egj * pre-operative staging ct3-4n+m0 * no prior other chemotherapy and/or radiation against the disease * normal function of all other vital organs including heart,liver ,kidney and so on * eastern cooperative oncology group performance status: 0\~2 exclusion criteria: * history of other malignancy * allergic reaction to capecitabine or oxaliplatin * enrolled in other clinical trials * abnormal gi tract function * dysfunction of other organs * pregnant or lactating females ,or refuse to receive contraception measures during chemotherapy * other situations judged as not adaptive to the study by investigators
randomized clinical trial of intravitreal bevacizumab versus intravitreal bevacizumab combined with losartan in the treatment of diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: the aim of this study is to determine whether oral losartan is effective in the treatment of diabetic macular edema (dme) as an adjuvant for intravitreal bevacizumab (ivb).


Eligibility criteria:
inclusion criteria: all type 2 diabetes mellitus patients with clinically significant macular edema(csme), except those mentioned as exclusion criteria exclusion criteria: 1. patients with uncontrolled hypertension 2. patients with proliferative diabetic retinopathy 3. patients who received angiotensin converting enzyme inhibitor(acei) or angiotensin receptor blocker(arb) 4. previous treatment for diabetic retinopathy (e.g., laser photocoagulation, photodynamic therapy, intravitreal injections of steroids, or anti-vascular endothelial growth factor, retinal surgery) 5. media opacities 6. evidence of any other ocular disease(e.g., glaucoma, uveitis, age related macular degeneration or etc.,) 7. pathologic myopia \> 6 diopter 8. patients with poor fixation or cooperation 9. patients with renal or cardiac disease
botanical/drug interactions in hiv: glucuronidation

Conditions: HIV Seronegativity

Summary: a series of clinical studies will be conducted in normal, healthy adult volunteers to evaluate the potential for alterations in the pharmacokinetics of anti hiv drugs when botanicals/nutriceuticals are given concurrently via the oral route. both the drugs and botanicals are known to rely upon or to modulate, respectively, metabolism via glucuronidation.

as per brief summary

Eligibility criteria:
inclusion criteria: * absence of hiv-1 infections * body mass index less than or equal to 30 kg/m2 and weigh at least 50 kg. * laboratory values obtained within 7 days of study entry within normal range for healthy volunteers. * able to be compliant with dosing schedules and diary record keeping. * able to follow dietary restrictions associated with the protocol. * ability and willingness to provide informed consent * all women of reproductive potential must have a negative pregnancy test * all women of reproductive potential to use contraception methods as defined by protocol * all study subjects (male and female) must agree to not participate in a conception process exclusion criteria: * history of any acute or chronic illness that requires current medical therapy including active gastrointestinal conditions that might interfere with drug absorption. * history of hepatic, renal, cardiovascular, gastrointestinal diseases. * current gastrointestinal disturbance. * receipt of any prescribed or over the counter medication or ingested cam during the 30 days prior to study entry except: over the counter acetaminophen or ibuprofen at doses not exceeding package labeling guidelines. * any medical condition that, in the opinion of the investigator, would interfere with the subject's ability to participate in this protocol. * pregnancy or breastfeeding. * allergy/sensitivity to study agent(s) or their formulations. * active drug or alcohol abuse or dependence, which in the opinion of the investigator would interfere with adherence to study requirements or would endanger the subject's health while on study. * before entering the study, subjects must agree not to consume alcohol for 48 hours prior to pk sampling days. * participation in any investigational drug studies within 30 days prior to study entry and during study.

Keywords: milk thistle silymarin piperine glucarate zidovudine abacavir mycophenolate mofetil hiv pharmacokinetics interaction glucuronidation healthy complementary therapies